IN.PACT™ Quality of Life Post-Reimbursement Study

IN.PACT™ QoL PSR

To prospectively collect and assess the perception of health-related Quality of Life, Pain and Walking Ability.

2021-02-17

2023-11-08

2024-12-01

Active (not recruiting)

80

Inclusion Criteria: * Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements * Patient has or is intended to receive or be treated with an eligible product * Patient is consented within the enrollment window of the treatment/therapy received Exclusion Criteria: * Patient who is, or is expected to be inaccessible for follow-up * Patient with exclusion criteria required by local law * Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results (i.e. no required intervention that could affect interpretation of all-around product safety and or effectiveness) Note: For this study, de novo patients will be enrolled to assess EQ-5D and WIQ at baseline and follow-up. Patients cannot be treated in the same procedure with a competitor drug-coated (DCB) or drug-eluting (DES) in the vessel segment treated with IN.PACT Admiral.

{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '24 Months', 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 80, 'type': 'ACTUAL'}}

2024-03-15